Ospemifene
Selective Estrogen Receptor Modulators
Sold as Senshio · OSPHENA
- Drug class
- Selective Estrogen Receptor Modulators
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Ospemifene is an active pharmaceutical ingredient in the Selective Estrogen Receptor Modulators group (G03XC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| EU European Union | EMA | 1 | November 25, 2024 |
GBUnited Kingdom· MHRA
1 product
Uses
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
How to take
Posology The recommended dose is one 60 mg tablet once daily with food taken at the same time each day. If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.
2). 2). Hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment. 2). Paediatric population There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women.
Method of administration Oral use. One tablet should be swallowed whole once daily with food and should be taken at the same time each day.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
5%). Tabulated list of adverse reactions Averse reactions are listed below by MedDRA preferred term system organ class and by frequency. Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Table 1 Adverse reactions MedDRA system organ class Common Uncommon Infections and infestations Vulvovaginal candidiasis / mycotic infections - Immune system disorders - Drug hypersensitivityb, Hypersensitivityb, Swollen tongue Nervous system disorders Headachec Vascular disorders Hot flushd - Skin and subcutaneous tissue disorders Rash (includes rash erythematous, rash generalised) Pruritus Urticaria Musculoskeletal and connective tissue disorders Muscle spasms - Reproductive system and breast disorders Vaginal discharge, Genital discharge, Vaginal haemorrhage Endometrial hypertrophya (sonographic endometrial thickness) a Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
b Hypersensitivity reactions including adverse reactions listed under skin and subcutaneous tissue disorders, swollen tongue, pharyngeal oedema and throat tightening were reported. 9%) groups. d Hot flushes including hyperhidrosis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
g. dyspareunia and vaginal dryness. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.
Ospemifene should only be continued as long as the benefit outweighs the risk. 8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.
If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy. 1). 2% in women who received placebo treatment.
Venous thromboembolic events (VTEs) The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective oestrogen receptor modulators (SERMs). The risk of VTE associated with ospemifene cannot be excluded.
Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE). The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.
, post-surgical recovery, prolonged bed rest). Treatment should be resumed only after the patient is mobilised. If VTE develops after initiating therapy, the treatment should be discontinued. g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Cerebro-vascular events The risk of cerebrovascular events is possibly increased with other SERMs. The risk of cerebrovascular events associated with ospemifene cannot be excluded. This should be considered when prescribing ospemifene for post-menopausal women with a history of stroke or other significant stroke risk factors.
Pre-existing gynaecological pathology other than signs of vaginal atrophy There are limited clinical trial data on the use of ospemifene in patients with other gynaecological conditions. It is recommended that any additional pathology be investigated and treated appropriately before starting ospemifene.
Breast cancer Ospemifene has not been formally studied in women with a prior history of breast cancer. No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer. Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Hot flushes Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2/3 clinical programme due to hot flushes.
5). If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts. Lactose content Senshio contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium content Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
1. - Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. - Unexplained vaginal bleeding. 4). g. endometrial cancer). - Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied.
This is not medical advice. Consult a qualified healthcare professional.
CACanada· Health Canada
1 product
Uses
Osphena (ospemifene tablets) is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).
1 Pediatrics Pediatrics (≤18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. Osphena is not indicated in children. 2 Geriatrics Geriatrics (≥65 years of age): Of the 2209 Osphena-treated women enrolled in the ten (10) Phase II/III trials of Osphena, >19 percent were 65 years of age or older.
No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 65 years of age.
How to take
1 Dosing Considerations The following situations may affect dosing of Osphena: Concomitant use of ospemifene with estrogens, estrogen agonist/antagonist, fluconazole, rifampin, ketoconazole, highly protein-bound drugs and drugs known to inhibit CYP3A4 and CYP2C9 (see Drug Interactions, Drug-Drug Interactions section).
Use of Osphena should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Osphena patients have significantly greater adherence and persistence compared with non-ring local estrogen therapies (LETs). 2 Recommended Dose and Dosage Adjustment One Osphena (ospemifene) 60 mg tablet with food once daily. No dose adjustment is required in women with any severity of renal impairment.
No dose adjustment is required with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see Warnings and Precautions section). Osphena should not be used in women with severe hepatic impairment (see Warnings and Precautions section).
Osphena is indicated for use in postmenopausal women. Osphena is not intended for use in children. Health Canada has not authorized an indication for pediatric use. 4 Administration Osphena (ospemifene) should be consistently taken orally with food, as the presence or absence of food may alter bioavailability.
5 Missed Dose In the event that a dose is missed, the next dose should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped and the next dose should be taken as planned. Doses should not be doubled to make up for a missed dose.
The prescribed dosing schedule should be continued.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
1 Adverse Reaction Overview The following serious adverse reactions are discussed elsewhere in the Product Monograph: Cardiovascular Disorders (see Warnings and Precautions, Cardiovascular section); Malignant Neoplasms (see Warnings and Precautions, Carcinogenesis and Mutagenesis section); The most frequent adverse reactions that occurred in patients treated with Osphena 60 mg once daily in the 12-week double-blind, placebo-controlled clinical trials were hot flush, hyperhidrosis, muscle spasms and vaginal discharge (see Table 2).
Pooled analysis of hot flush treatment-emergent adverse events (TEAEs) found that the frequency of hot flushes declined after 4 weeks of ospemifene treatment. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating drug-related adverse events and for approximating rates.
The safety of Osphena has been assessed in ten (10) Phase II/III trials (n=2209) with doses ranging from 5 to 90 mg per day. The duration of treatment in these studies ranged from 6 weeks to 15 months. Most women (n=1683) had a treatment period of at least 12 weeks, 432 had at least 52 weeks (1 year) of exposure.
The long-term safety in patients that had at least 52 weeks of exposure is similar to those listed in Table 2. 15 (1 case of thromboembolic stroke) and 0 per thousand women years, respectively in placebo. 15 (1 case of DVT) in placebo.
The incidence of pulmonary embolism was 0 per thousand women years in the Osphena 60 mg and placebo treatment groups. Table 2 below lists adverse reactions occurring more frequently in the Osphena 60 mg treatment group than in placebo and at a frequency ≥1%.
0% in the Osphena Treatment Group (60 mg Once Daily) in the 12-Week Double-Blind, Controlled Clinical Trials with Osphena vs. 1% and < 1% but exceeding the placebo rate that occurred in women treated with Osphena in the 12-week double-blind, controlled <OSPHENA>< ospemifene tablets > Product Monograph Page 11 of 33 Phase III clinical trials.
5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of Osphena. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders:
Allergic conditions including hypersensitivity, angioedema Nervous System Disorders: Headache Skin and Subcutaneous Tissue Disorders: Rash, rash erythematous, rash generalized, pruritus, urticaria Vascular Disorders: deep vein thrombosis, thrombosis, pulmonary embolism
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Carcinogenesis and Mutagenesis Endometrial Cancer:
Osphena (ospemifene tablets) is an estrogen receptor agonist/antagonist with tissue selective effects. In the endometrium, Osphena has weak agonistic effects. In the Osphena clinical trials (60 mg treatment group), no cases of endometrial cancer were seen with exposure up to 52 weeks.
There was a single case of simple hyperplasia without atypia. 5 per thousand women vs. 8 per thousand women for placebo. 3 per thousand women in the Osphena > 52 weeks treatment groups vs. 0 per thousand women for placebo. 9 per thousand women for placebo.
An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in non-users and appears dependent on duration of treatment and on estrogen dose.
Most studies show no significant increased risk associated with the use of estrogens for less than 1 year. The greatest risk appears to be associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more.
This risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Adding a progestin to postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer. The use of progestins with OSPHENA therapy was not evaluated in the clinical trials.
Clinical surveillance of all women using Osphena is important. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Breast Cancer:
Osphena (ospemifene tablets) 60 mg has not been adequately studied in women with breast cancer; therefore, it should not be used in women with known or suspected breast cancer. Cardiovascular Risk factors for cardiovascular disorders, arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus), should be managed appropriately.
15 and 0 per thousand women years in placebo. Should thromboembolic or hemorrhagic stroke occur or be suspected, Osphena should be discontinued immediately. 625 mg)-alone compared to women in the same age group receiving placebo (45 versus 33 per ten thousand women years).
The increase in risk was demonstrated in year 1 and persisted.
Coronary Heart Disease:
In the Osphena clinical trials, two cases of myocardial infarctions (MI) occurred in women receiving 60 mg of ospemifene. In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo.
15 per thousand women years in placebo. The incidence of pulmonary embolism (PE) was 0 per thousand women years in the Osphena 60 mg and placebo treatment groups. Should a VTE (including DVT and PE) occur or be suspected, Osphena should be discontinued immediately.
If feasible, Osphena should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 625 mg)-alone compared to placebo (30 versus 22 per ten thousand women years), although only the increased risk of DVT reached statistical significance (23 versus 15 per ten thousand women years).
The increase in VTE risk was demonstrated during the first 2 years. Genitourinary Vaginal Bleeding Abnormal vaginal bleeding, due to its prolongation, irregularity or heaviness, occurring during therapy should prompt appropriate diagnostic measures to rule out the possibility of uterine malignancy and the treatment should be re-evaluated.
Hepatic/Biliary/Pancreatic Osphena 60 mg should not be used in women with severe hepatic impairment (see Pharmacokinetics, Hepatic Insufficiency section).
Reproductive Health:
Female and Male Potential Fertility <OSPHENA>< ospemifene tablets > Product Monograph Page 9 of 33 Osphena is indicated in postmenopausal women with no childbearing potential. Osphena is contraindicated in women who are or may become pregnant (see Contraindications and Warnings and Precautions, Special Populations […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
Osphena is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Osphena is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding Known or suspected estrogen-dependent neoplasia Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions Active arterial thromboembolic disease [for example, stroke and myocardial infarction (MI)], or a history of these conditions Severe hepatic impairment (see Warnings and Precautions section) Women who are or may become pregnant.
Ospemifene may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2.
If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus (see Warnings and Precautions, Special Populations section). Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) <OSPHENA>< ospemifene tablets > Product Monograph Page 5 of 33
This is not medical advice. Consult a qualified healthcare professional.
Brands in Canada (1)
EUEuropean Union· EMA
1 product
Uses
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
How to take
Posology The recommended dose is one 60 mg tablet once daily with food taken at the same time each day. If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.
2). 2). Hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment. 2). Paediatric population There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women.
3 Method of administration Oral use. One tablet should be swallowed whole once daily with food and should be taken at the same time each day.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
5%). Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from available data).
Table 1 Adverse reactions MedDRA system organ class Common Uncommon Infections and infestations Vulvovaginal candidiasis / mycotic infections - Immune system disorders - Drug hypersensitivityb, Hypersensitivityb, Swollen tongue Nervous system disorders Headachec Vascular disorders Hot flushd - Skin and subcutaneous tissue disorders Rash (includes rash erythematous, rash generalised) Pruritus Urticaria Musculoskeletal and connective tissue disorders Muscle spasms - Reproductive system and breast disorders Vaginal discharge, Genital discharge, Vaginal haemorrhage Endometrial hypertrophya (sonographic endometrial thickness) a Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
b Hypersensitivity reactions including adverse reactions listed under skin and subcutaneous tissue disorders, swollen tongue, pharyngeal oedema and throat tightening were reported. 9%) groups. d Hot flushes including hyperhidrosis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7
g. dyspareunia and vaginal dryness. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.
Ospemifene should only be continued as long as the benefit outweighs the risk. 8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.
If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy. 1). 2% in women who received placebo treatment.
Venous thromboembolic events (VTEs) The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective oestrogen receptor modulators (SERMs). The risk of VTE associated with ospemifene cannot be excluded.
Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI> 30 kg/m2) and systemic lupus erythematosus (SLE). The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.
, post-surgical recovery, prolonged bed rest). Treatment should be resumed only after the patient is mobilised. If VTE develops after initiating therapy, the treatment should be discontinued. g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
4 Cerebro-vascular events The risk of cerebrovascular events is possibly increased with other SERMs. The risk of cerebrovascular events associated with ospemifene cannot be excluded. This should be considered when prescribing ospemifene for post-menopausal women with a history of stroke or other significant stroke risk factors.
Pre-existing gynaecological pathology other than signs of vaginal atrophy There are limited clinical trial data on the use of ospemifene in patients with other gynaecological conditions. It is recommended that any additional pathology be investigated and treated appropriately before starting ospemifene.
Breast cancer Ospemifene has not been formally studied in women with a prior history of breast cancer. No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer. Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Hot flushes Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2/3 clinical programme due to hot flushes.
5). If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts. Lactose content Senshio contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium content Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
1. - Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. - Unexplained vaginal bleeding. 4). g. endometrial cancer). - Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied.
This is not medical advice. Consult a qualified healthcare professional.
Brands in European Union (1)
Drug interactions
Known interactions involving Ospemifene. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB509990001 · revised May 15, 2026
- [2]Health Canada (DPD) · 02518112 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/002780 · revised November 25, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.